title: Quantitative and qualitative analysis of study-related patient information sheets in randomised neuro-oncology phase III-trials.
abstract: BACKGROUND
  In randomised controlled trials (RCTs), patient informed consent documents are an essential cornerstone of the study flow. However, these documents are often oversized in format and content. Clinical experience suggests that study information sheets are often not used as an aid to decision-making due to their complexity.
  
  
  METHODS
  We analysed nine patient informed consent documents from clinical neuro-oncological phase III-studies running at a German Brain Tumour Centre with the objective to investigate the quality of these documents. Text length, formal layout, readability, application of ethical and legal requirements, scientific evidence and social aspects were used as rating categories. Results were assessed quantitatively by two independents investigators and were depicted using net diagrams.
  
  
  RESULTS
  All patient informed consent documents were of insufficient quality in all categories except that ethical and legal requirements were fulfilled. Notably, graduate levels were required to read and understand five of nine consent documents.
  
  
  CONCLUSIONS
  Quality deficits were consistent between the individual study information texts. Irrespective of formal aspects, a document that is intended to inform and motivate patients to participate in a study needs to be well-structured and understandable. We therefore strongly mandate to re-design patient informed consent documents in a patient-friendly way. Specifically, standardised components with a scientific foundation should be provided that could be retrieved at various times, adapted to the mode of treatment and the patient's knowledge, and could weigh information dependent of the stage of treatment decision.
authors.affiliation: Department of Neurology and Wilhelm Sander NeuroOncology Unit, University Hospital Regensburg, Franz Josef Strauß-Allee 11, 93047 Regensburg, Germany.
authors.forename: Christiane
authors.initials: C
authors.lastname: Reinert
authors.affiliation: Department of Neurology and Wilhelm Sander NeuroOncology Unit, University Hospital Regensburg, Franz Josef Strauß-Allee 11, 93047 Regensburg, Germany.
authors.forename: Lukas
authors.initials: L
authors.lastname: Kremmler
authors.affiliation: EORTC Headquarters, Avenue E. Mounier 83/11, 1200 Brussels, Belgium.
authors.forename: Susen
authors.initials: S
authors.lastname: Burock
authors.affiliation: Department of Neurology and Wilhelm Sander NeuroOncology Unit, University Hospital Regensburg, Franz Josef Strauß-Allee 11, 93047 Regensburg, Germany.
authors.forename: Ulrich
authors.initials: U
authors.lastname: Bogdahn
authors.affiliation: Division of Neuro Oncology, University of Heidelberg and National Center for Tumor Diseases, Im Neuenheimer Feld 400, 69120 Heidelberg, Germany.
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Wick
authors.affiliation: CenTrial GmbH, University Hospital Tübingen, Paul-Ehrlich-Str. 5, 72076 Tübingen, Germany.
authors.forename: Christoph H
authors.initials: CH
authors.lastname: Gleiter
authors.affiliation: Center for Clinical Studies, University Hospital Regensburg, Franz-Josef-Strauss-Allee 11, 93053 Regensburg, Germany.
authors.forename: Michael
authors.initials: M
authors.lastname: Koller
authors.affiliation: Department of Neurology and Wilhelm Sander NeuroOncology Unit, University Hospital Regensburg, Franz Josef Strauß-Allee 11, 93047 Regensburg, Germany. Electronic address: peter.hau@medbo.de.
authors.forename: Peter
authors.initials: P
authors.lastname: Hau
mesh_terms: D001932:Brain Neoplasms / Q000523:psychology / Q000628:therapy; D017326:Clinical Trials, Phase III as Topic / Q000941:ethics* / Q000592:standards; D032962:Consent Forms / Q000941:ethics / Q000592:standards*; D004992:Ethics, Medical; D005069:Evaluation Studies as Topic; D006801:Humans; D007258:Informed Consent / Q000941:ethics / Q000523:psychology / Q000592:standards*; D009423:Nervous System Neoplasms / Q000523:psychology / Q000628:therapy; D017410:Practice Guidelines as Topic; D016032:Randomized Controlled Trials as Topic / Q000941:ethics* / Q000592:standards
keywords: Clinical trial; Ethics; Informed consent; Neuro-oncology; Patient information; Qualitative analysis